Home or Home-like Hospital Birth

Pregnancy Clinical Trial

Official title:

Home or Home-like Hospital Birth for Low-risk Nulliparae: Does it Matter?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00237601
• Other study ID #: PF 198
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: April 1, 2010
• Start date: January 2006
• Est. completion date: December 2008

Study information

• Verified date: April 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

In the Netherlands, which has about 200.000 births per year, maternity care is provided by midwives or general practitioners unless medical reasons necessitate specialist obstetric care. Women with low risk pregnancies are free to decide where to give birth, attended by their midwife or general practitioner, at home or in the hospital, from which they are then discharged within 24 hours. In the Netherlands these hospital births are referred to as "poliklinische bevallingen" (i.e. outpatient deliveries) to indicate that they do not involve formal hospitalisation, or as "verplaatste thuisbevalling" (i.e. relocated home births) to indicate that they are supervised by the same caregivers as the home births without involvement of specialist obstetricians.

In the last two decades a marked increase in the referral rate to obstetricians during childbirth has occurred, especially for nulliparae, both in planned home births and planned hospital births (outpatient deliveries). 90% from all primigravidae will start their pregnancy under care of the primary caregiver (midwife of general practitioner). During the pregnancy 30% will be referred to the secondary caregiver (obstetrician specialist). The other 60% will start labor guided by the primary caregiver. More than 50% of these women will be referred to the obstetrician during labor.

Despite this unique situation of the Dutch maternity care, the differences between home and hospital birth (outpatient deliveries) with regard to effectivity and efficiency have never been investigated. It is also unclear if pregnant women are informed about a 50% risk of being transported to the secondary caregiver/ hospital during labor at home. Neither do we know what their experiences are.

This study aims to investigate the differences between home and hospital deliveries under care of the primary caregiver with regard to effectivity (costs) and efficiency (patient satisfaction) of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Primiparae

• No medical indication for specialistic care

• The pregnant woman will be able to give birth at home or at a hospital

• The woman and her partner will be fluent in the Dutch language

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• obstetric care

Locations

Country	Name	City	State
Netherlands	Academic Hospital Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	School for Midwifery Maastricht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary outcome: referral rate to secondary care, preferences of women and partners with regard to place of birth. Secondary outcome: costs of home birth and hospital births satisfaction of obstetric care			No